Pulmonx said today that it raised $65 million in an oversubscribed equity round and added that it picked up Derrick Sung as its new chief financial officer. Funding in the round was lead by Ally Bridge Group and joined by newly invested RTW Investments, ArrowMark Partners, Driehaus Capital Management and existing investors, the Redwood City, […]
A combination drug-device therapy developed by GlaxoSmithKline(NYSE:GSK) and Innoviva (NSDQ:INVA) for asthma, Trelegy Ellipta, met the primary endpoint in its pivotal trial, the companies said last week. The Trelegy Ellipta inhaler is designed to deliver a single daily dose of three drugs – fluticasone furoate, umeclidinium and vilanterol – to patients with uncontrolled asthma. The 2,436-patient Captain trial […]
The FDA today granted premarket approval to Xvivo Perfusion for its Xvivo Perfusion system with Steen solution perfusate intended to temporarily ventilate, oxygenate and pump preservation solution through lungs intended for transplantation procedures. The system is designed for use with lungs initially thought to be unacceptable for transplant, and allows a transplant team to perform […]
Pulmatrix (NSDQ:PULM) said yesterday that it inked a deal with Cipla to co-develop and commercialize an inhaled iSperse formulation of the anti-fungal drug itraconazole, intended for treating allergic bronchopulmonary aspergillosis in asthma patients. Lexington, Mass.-based Pulmatrix said that it in the deal, Cipla’s Cipla Tech subsidiary will make an upfront payment of $22 million to Pulmatrix […]
More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant. Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned. The letter from Cardinal Health (Dublin, […]
The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA. The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to […]
British medical device firm Bedfont said today that it won FDA 510(k) clearance for its ToxCO breath analysis monitor designed to measure exhaled carbon monoxide to indicate levels of CO in the blood. The newly cleared system is intended for use in triaging cases of CO poisoning as it provides instant results at the point-of-care, […]
Privately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome. The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer. Get the full story at our sister site, Drug Delivery Business News.
Novartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease. The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide. Get the full story at our sister site, Drug Delivery Business News.
Royal Philips (NYSE:PHG) yesterday released results from a study exploring the use of adaptive servo ventilation in treating patients with complex sleep apnea. Results from the study were published in the American Journal of Respiratory and Critical Care Medicine, the Amsterdam-based company said. Investigators in the study compared the performance of four different ASV devices, including […]
ResMed (NYSE:RMD) said today that it bought Korean home healthcare equipment supplier HB Healthcare for an undisclosed amount. San Diego-based ResMed said the acquisition is aimed at extending its decade-old footprint in South Korea to “millions more patients through HBH and its wider network of trusted distributor partners.” “ResMed has reaffirmed its leading role in Korea’s […]